KNG · Class II · 21 CFR 884.2660

FDA Product Code KNG: Monitor, Ultrasonic, Fetal

Leading manufacturers include Edan Instruments, Inc., Huntleigh Technology, Inc. and Contec Medical Systems Co.,Ltd.

60
Total
60
Cleared
146d
Avg days
1976
Since
60 devices
25–48 of 60
Cleared May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480
Edan Instruments, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
K033156
D. E. Hokanson, Inc.
Radiology · 70d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504
Koven Technology, Inc.
Radiology · 65d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143
Koven Technology, Inc.
Radiology · 90d
Cleared Dec 28, 1999
CADENCE DOPPLER ULTRASOUND SYSTEM
K991441
Medasonics, Inc.
Radiology · 246d
Cleared Jun 20, 1991
OBTRASOUND STETHOSCOPE FETAL CALC
K911453
Medasonics, Inc.
Radiology · 78d
Cleared Mar 29, 1991
UST-974-5 CONVEX TRANSDUCER
K910153
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 74d
Cleared Jul 02, 1990
IMEX DOP-TONE II
K901593
Imex Medical Systems, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 25, 1990
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 76d
Cleared Jul 09, 1986
HUNTLEIGH DOPCORD, D140
K854267
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 259d
Cleared Jan 08, 1983
PROGRAMALITH PROGRAMMER
K823242
Pacesetter Systems
Obstetrics & Gynecology · 68d
Cleared Jul 16, 1981
DOPPLEX-PLB & PXB
K810115
Huntleigh Technology, Inc.
Radiology · 181d
Cleared May 14, 1980
FETAL HEART DETECTOR #'S D102 & D102R
K800858
Sonicaid, Inc.
Obstetrics & Gynecology · 29d
Cleared May 14, 1980
FETAL HEART DETECTOR #D206
K800859
Sonicaid, Inc.
Obstetrics & Gynecology · 29d